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EP4476525B1 - Méthode de détermination d'un intervalle d'attente de couleur pour évaluer la plausibilité d'une valeur supposée de temps de réaction utilisée dans une mesure analytique basée sur une réaction de formation de couleur, système et dispositif mobile - Google Patents

Méthode de détermination d'un intervalle d'attente de couleur pour évaluer la plausibilité d'une valeur supposée de temps de réaction utilisée dans une mesure analytique basée sur une réaction de formation de couleur, système et dispositif mobile

Info

Publication number
EP4476525B1
EP4476525B1 EP23703456.6A EP23703456A EP4476525B1 EP 4476525 B1 EP4476525 B1 EP 4476525B1 EP 23703456 A EP23703456 A EP 23703456A EP 4476525 B1 EP4476525 B1 EP 4476525B1
Authority
EP
European Patent Office
Prior art keywords
color
values
training set
images
color formation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP23703456.6A
Other languages
German (de)
English (en)
Other versions
EP4476525A1 (fr
Inventor
Max Berg
Fredrik HAILER
Bernhard Limburg
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
F Hoffmann La Roche AG
Roche Diabetes Care GmbH
Original Assignee
F Hoffmann La Roche AG
Roche Diabetes Care GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by F Hoffmann La Roche AG, Roche Diabetes Care GmbH filed Critical F Hoffmann La Roche AG
Publication of EP4476525A1 publication Critical patent/EP4476525A1/fr
Application granted granted Critical
Publication of EP4476525B1 publication Critical patent/EP4476525B1/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/27—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands using photo-electric detection ; circuits for computing concentration
    • G01N21/272—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands using photo-electric detection ; circuits for computing concentration for following a reaction, e.g. for determining photometrically a reaction rate (photometric cinetic analysis)
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/5005—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
    • G01N33/5008—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N21/78—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/84—Systems specially adapted for particular applications
    • G01N21/8483—Investigating reagent band
    • G—PHYSICS
    • G06—COMPUTING OR CALCULATING; COUNTING
    • G06T—IMAGE DATA PROCESSING OR GENERATION, IN GENERAL
    • G06T7/00—Image analysis
    • G06T7/90—Determination of colour characteristics
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/40—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H30/00—ICT specially adapted for the handling or processing of medical images
    • G16H30/40—ICT specially adapted for the handling or processing of medical images for processing medical images, e.g. editing
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/70—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for mining of medical data, e.g. analysing previous cases of other patients
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N2021/755—Comparing readings with/without reagents, or before/after reaction
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N2021/7756—Sensor type
    • G01N2021/7759—Dipstick; Test strip
    • G—PHYSICS
    • G06—COMPUTING OR CALCULATING; COUNTING
    • G06T—IMAGE DATA PROCESSING OR GENERATION, IN GENERAL
    • G06T2207/00—Indexing scheme for image analysis or image enhancement
    • G06T2207/20—Special algorithmic details
    • G06T2207/20081—Training; Learning

Definitions

  • the present invention refers to a determination method of determining at least one color expectation range for assessing the plausibility of an assumed reaction time value.
  • the invention further relates to a measurement method of performing an analytical measurement based on a color formation reaction.
  • the invention relates to a determination system and to a mobile device as well as to computer programs, computer-readable storage media and a kit.
  • the methods, systems, mobile devices, the computer programs, the computer-readable storage media and the kit may be used specifically in medical diagnostics, in order to for example quantitatively or qualitatively detect one or more analytes in one or more body fluids and/or bodily fluids, such as for detecting glucose in blood and/or interstitial fluid.
  • Other fields of application of the present invention are feasible.
  • analytes In the field of medical diagnostics, in many cases, one or more analytes have to be detected in samples of a body fluid, such as blood, interstitial fluid, urine, saliva or other types of body fluids.
  • a body fluid such as blood, interstitial fluid, urine, saliva or other types of body fluids.
  • analytes to be detected are glucose, triglycerides, lactate, cholesterol or other types of analytes typically present in these body fluids.
  • an appropriate treatment may be chosen, if necessary.
  • the invention specifically may be described with respect to blood glucose measurements. It shall be noted, however, that the present invention may also be used for other types of analytical measurements using test elements.
  • test elements and/or test strips comprising one or more test chemicals, which, in presence of the analyte to be detected, are capable of performing one or more detectable detection reactions, such as optically detectable detection reactions.
  • detectable detection reactions such as optically detectable detection reactions.
  • test chemicals comprised in test elements and/or test strips reference may be made e.g. to J. Hoenes et al.: The Technology Behind Glucose Meters: Test Strips, Diabetes Technology & Therapeutics, Volume 10, Supplement 1, 2008, S-10 to S-26 .
  • Other types of test chemistry are possible and may be used for performing the present invention.
  • US 2020/0249220 A1 describes a method of detecting a urine test strip from a photographed image of the urine test strip.
  • the disclosed method of detecting a urine test strip includes: receiving input of a urine test strip image, which is a photographed image of a urine test strip including a first and a second marker; detecting a first and a second marker image within the urine test strip image; detecting an area between the first and second marker images within the urine test strip image; and detecting a reagent pad and a colorimetric table in the urine test strip image by matching an area of interest, which represents a position of the reagent pad and the colorimetric table in the urine test strip image, with the area between the first and second marker images.
  • US 9,787,815 B2 describes a method for obtaining a point-of-collection, selected quantitative indicia of an analyte on a test strip using a smartphone that involves imaging a test strip on which a colorimetric reaction of a target sample has occurred due to test strip illumination by the smartphone.
  • the smartphone includes a smartphone app and a smartphone accessory that provides an external environment-independent/internal light-free, imaging environment independent of the smartphone platform being used.
  • the result can then be presented quantitatively or turned into a more consumer-friendly measurement (positive, negative, above average, etc.), displayed to the user, stored for later use, and communicated to a location where practitioners can provide additional review.
  • social media integration can allow for device results to be broadcast to specific audiences, to compare healthy living with others, to compete in health based games, create mappings, and other applications.
  • EP 2 916 117 A1 describes color quantification of chemical test pads and titration of analytes that can be performed under different lighting conditions.
  • the lighting condition is estimated under which a digital image is captured and utilized to select a set of reference colors from which the quantified color is compared to determine the titration.
  • a plurality of comparisons is made with different lighting conditions with the result having the highest confidence level being selected to determine the titration.
  • EP 1 963 828 B1 describes a method for measuring a concentration of an analyte contained in a sample of a biological fluid.
  • a test strip is provided which comprises at least one test point and at least one reference color section encompassing the color white and/or a color scale.
  • the fluid sample is brought in contact with the test point, and a color indicator is disposed on the test point in accordance with the concentration of the analyte.
  • a camera is placed on the test strip. At least one measured value is detected for the relative position between the camera and the test strip and is compared to a set value range. If the measured value deviates from the set value range, the camera is moved relative to the test strip to reduce the deviation.
  • a colored image on which at least the color indicator and the reference color section are represented is detected with the aid of the camera.
  • the image areas assigned to the color indicator and the color matching section are located, and the color values of said image areas are determined.
  • the analyte concentration in the sample is determined based on the color values with the aid of predefined comparative values.
  • US 2015/0241358 A1 describes in one embodiment an apparatus for automatic test diagnosis of a test paddle.
  • the apparatus comprises a personal computing device including: a camera to capture images over time of test pads of a test paddle, a processor coupled to the camera, and a display device coupled to the processor.
  • the processor analyzes the color changes over time of each test pad to determine a color trajectory over time for each test pad.
  • the processor compares the color evolution trajectory for each test pad with color calibration curves for each test pad to determine an analyte concentration of a test biological sample, such as urine.
  • the display device displays a user interface with results of the analyte concentration in response to the analysis over time.
  • US 2014/065647 A1 describes a system and method for spatiotemporally analyzed rapid assays.
  • EP 3 667 301 A1 describes a method an system for determining concentration of an analyte in a sample of a bodily fluid, and a method and system for generating a software implemented module.
  • US 2021/299651 A1 describes a multi-factor urine test system that adjusts for lighting and timing.
  • US 2017/098137 A1 describes a method, apparatus and system for detecting and determining compromised reagent pads by quantifying color changes induced by exposure to a hostile environment.
  • US 2006/246574 A1 describes a dispenser for building a lateral flow immunoassay device comprising a fluid supply assembly and a jetting assembly.
  • the terms “have”, “comprise” or “include” or any arbitrary grammatical variations thereof are used in a non-exclusive way. Thus, these terms may both refer to a situation in which, besides the feature introduced by these terms, no further features are present in the entity described in this context and to a situation in which one or more further features are present.
  • the expressions “A has B”, “A comprises B” and “A includes B” may both refer to a situation in which, besides B, no other element is present in A (i.e. a situation in which A solely and exclusively consists of B) and to a situation in which, besides B, one or more further elements are present in entity A, such as element C, elements C and D or even further elements.
  • the terms "at least one”, “one or more” or similar expressions indicating that a feature or element may be present once or more than once typically will be used only once when introducing the respective feature or element.
  • the expressions “at least one” or “one or more” will not be repeated, non-withstanding the fact that the respective feature or element may be present once or more than once.
  • a determination method of determining at least one color expectation range for assessing the plausibility of an assumed reaction time value used in an analytical measurement based on a color formation reaction comprises the following steps that, as an example, may be performed in the given order. It shall be noted, however, that a different order may generally also be possible. Further, it may also be possible to perform one or more of the method steps once or repeatedly. Further, it may also be possible to perform two or more of the method steps simultaneously or in a timely overlapping fashion. The determination method may comprise further method steps that are not listed.
  • the determination method comprises:
  • an analytical measurement based on a color formation reaction is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term specifically may refer, without limitation, to a quantitative and/or qualitative determination of at least one analyte in an arbitrary sample or aliquot of bodily fluid by using a color formation reaction.
  • the bodily fluid may comprise one or more of blood, interstitial fluid, urine, saliva or other types of body fluids.
  • the result of the determining of the analyte as an example, may be a concentration of the analyte and/or the presence or absence of the analyte to be determined.
  • the analytical measurement may be a blood glucose measurement
  • the result of the analytical measurement may for example be a blood glucose concentration
  • an analytical measurement result value such as the concentration of the analyte in the bodily fluid
  • a color formation reaction such as a color-change reaction in response to a quantitative and/or qualitative presence or absence of the analyte in the bodily fluid.
  • the bodily fluid may comprise one or more of blood, interstitial fluid, urine, saliva or other types of body fluids.
  • sample of bodily fluid may specifically refer to an arbitrary aliquot part or aliquant part of a biological fluid which directly is a bodily fluid or which is derived from a bodily fluid such as by one or more pre-processing steps, e.g. by centrifugation.
  • the sample of bodily fluid may be a droplet of a body fluid as gathered from the body of a person, such as a droplet of blood and/or interstitial fluid generated, e.g., by piercing of a skin portion of the person, e.g. with a lancet, a needle or the like.
  • the sample of bodily fluid may also be simply referred to as the sample.
  • optical test strip In the analytical measurement based on a color formation reaction specifically an optical test strip is used.
  • optical test strip As used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term specifically may refer, without limitation, to an arbitrary element or device configured for performing a color-change detection reaction.
  • the optical test strip may also be referred to as test strip or test element, wherein all three terms may refer to the same element.
  • the optical test strip may particularly have a reagent test region, also referred to as test region and/or test field, containing at least one test chemical for detecting at least one analyte.
  • the test chemical may be configured for performing a color-change, e.g. changing its color, due to a presence of the analyte.
  • the color-change may for example depend on a concentration of the analyte in the sample of bodily fluid.
  • the reagent test region may have a visually detectable edge, such as a detectable rim and/or border, contrasting the reagent test region from other parts of the optical test strip.
  • the optical test strip may comprise at least one substrate, such as at least one carrier, with the at least one test field applied thereto or integrated therein.
  • the optical test strip may further comprise at least one white area, such as a white field, specifically in a proximity to the reagent test region, for example enclosing or surrounding the test region.
  • a contrast between the reagent test region and the white area surrounding the reagent test region may be sufficient to allow visually detecting an edge and/or rim of the reagent test region.
  • the substrate or carrier itself may be or may comprise the white area.
  • the at least one carrier may be strip-shaped, thereby rendering the test element a test strip.
  • an assumed reaction time value used in an analytical measurement based on a color formation reaction is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term specifically may refer, without limitation, to a numerical indication of a reaction time that is estimated in an analytical measurement.
  • the reaction time value may refer to a time that has passed for a color-change reaction of the reagent test region of the optical test strip.
  • the assumed reaction time value may, in the analytical measurement, be provided by a user, e.g. a user performing the analytical measurement.
  • the user may be required to provide information, such as a time of sample application onto the reagent test region, allowing to assume and/or predict a reaction time value also referred to as the assumed reaction time value.
  • the assumed reaction time value may refer to an assumed and/or estimated time between sample application to the reagent test region and the measurement, i.e. between a triggering of the color change reaction and a capturing of an image of the reagent test region.
  • the assumed reaction time value may also be referred to as an assumed capture time value, such as an assumed value for a capture time value, as will be outlined below.
  • the term "assumed reaction time value”, or synonymously the term “assumed capture time value”, as used herein is a broad term is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term specifically may refer, without limitation, to an assumed and/or predicted numerical indication of a reaction time, i.e. of a time during which a chemical reaction, specifically a color-change reaction, has happened.
  • the assumed reaction time value may refer to a time during which a chemical reaction has happened and may thus also be referred to as chemical reaction timing and/or color-change reaction timing.
  • the assumed reaction time value may specifically be an estimated and/or predicted time value, e.g.
  • the assumed reaction time value may differ from the actual reaction time that may have passed for the color-change reaction of the reagent test region.
  • the assumed reaction time value may be used for determining the analyte concentration from a color formation value.
  • the assumed reaction time value may refer to an assumed and/or predicted numerical indication of a reaction time range, i.e. of a time range during which the chemical reaction, specifically the color-change reaction, has happened.
  • the assumed reaction time value may additionally or alternatively indicate a numerical range of time, such as a time range, e.g. "within 1 minute” or "between 13 and 45 seconds".
  • color formation value may refer to an arbitrary numerical indication, such as numerical representation, of the color of the reagent test region of the test strip, specifically resulting from the color-change detection reaction of the test chemical.
  • the color numerically indicated by the color formation value may correlate with an analyte concentration of the sample of bodily fluid applied to the respective optical test strip.
  • the color and therefore the color formation value may correlate with a blood glucose value and/or blood glucose concentration.
  • the color of the reagent test region, and thus the color formation value may change over time.
  • the correlation between the color formation value and the analyte concentration may further be time-dependent. Therefore, in the analytical measurement, the analyte concentration may be determined from the color formation value by further using the assumed reaction time value.
  • the correlation may be represented by one or more functions, wherein the analyte concentration may be determined by inserting into the function the assumed reaction time value and the color formation value.
  • the assumed reaction time value may be inserted as a numerical value.
  • different mathematical correlation functions may be used for different assumed reaction time values.
  • a first mathematical correlation function may be used for determining the analyte concentration from the color formation value
  • a second mathematical correlation function may be used for a second time range of the assumed reaction time value.
  • a mathematical function " f " may be used for an assumed reaction time value "between 13 and 45 seconds”
  • a mathematical function "g” may be used for an assumed reaction time value "between 45 and 120 seconds”.
  • the analytical measurement may even be aborted, e.g. by displaying an error message on a display of the mobile device.
  • the function "g" may be determinable from the function " f " corrected by using a predetermined correction function, e.g. applying a correction value.
  • Other forms of functions may be used for representing the correlation between the analyte concentration and the color formation value may be used, for example look-up tables or interpolations.
  • the assumed reaction time value may be used for selecting the function, such as "f” or "g", to be used for determining the analyte concentration from the color formation value, wherein, however, in the calculation of the analyte concentration itself, i.e. when using and/or applying the mathematical function, i.e. "f” or "g", the assumed reaction time value may not be used or may even be irrelevant.
  • assessing the plausibility is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term specifically may refer, without limitation, to a process of quantitatively and/or qualitatively determining a credibility and/or probability of an element and/or data.
  • the plausibility may be assessed by using one or more characteristic parameters and/or properties of the element and/or data. These one or more characteristic parameters and/or properties may, individually or according to a predetermined combination, be compared with one or more conditions.
  • the plausibility of the assumed reaction time value may be assessed by using one or more characteristic parameters and/or properties of an expected characteristic, specifically by using the color expectation range as will be outlined in further detail below.
  • the respective color formation value may be compared to the color expectation range, e.g. to one or more comparative values, reference values or standard values, wherein the comparison may be a qualitative or quantitative comparison and may result in a binary result such as "plausible” or “not plausible”/"implausible". Additionally or alternatively, however, the comparison may result in a quantitative result, such as a figure indicating a degree of plausibility.
  • color expectation range is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term specifically may refer, without limitation, to a continuous and/or discrete scope of a color space within which a color is expected and/or predicted to be for a range of predefined reaction time values, i.e. for a predefined reaction time value range.
  • the color expectation range may be one or more of a one-dimensional, two-dimensional or three-dimensional area of a color space comprising at least one of comparative values, reference values and/or standard values, for a predefined reaction time value range.
  • the color expectation range may be or may comprise a continuous area and/or corridor comprising at least one expected color value. Additionally or alternatively, however, the color expectation range may be or may comprise a conglomerate of discrete expected colors, e.g. comprising discrete comparative values, reference values and/or standard values. In particular, the color expectation range, specifically a two-dimensional or three-dimensional color expectation range, may have an arbitrary form and/or shape.
  • in-time capture time values and tolerably delayed capture time values may be used in order to set and/or predefine the reaction time value range on which later, i.e. in a measurement method, the plausibility assessment may be based.
  • the term "determination method of determining at least one color expectation range for assessing the plausibility of an assumed reaction time value used in an analytical measurement based on a color formation reaction”, also simply referred to as a “determination method”, as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term specifically may refer, without limitation, to a method of determining the color expectation range as defined above, specifically according to a predefined reaction time value, i.e. to in-time capture time values and tolerably delayed capture time values.
  • the term may refer to a method by which, i.e. as a result, at least one range defining an expected range of color formation values is determined and/or ascertained, in particular for in-time capture time values and tolerably delayed capture time values as will be outlined further below.
  • capture time value is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term specifically may refer, without limitation, to a numerical indication of a time that has passed between a sample application, such as the sample application in step b) of the determination method, and a capturing of an image, such as the capturing of images in step c).
  • the capture time value may be specific to one captured image.
  • the capture time value may refer to the actual time that has passed between sample application and image capturing and may thus differ from the assumed reaction time value used in the analytical measurement.
  • in-time capture time value is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term specifically may refer, without limitation, to a capture time value that is within a predefined time range considered to be "punctual" and "in time".
  • all capture time values that fulfill a predefined punctuality requirement, i.e. are within the predefined time range may be referred to as "in-time capture time values”.
  • the in-time capture time values may be or may comprise capture time values within a predefined time range, such as within a previously set and/or defined time range.
  • the predefined time range and/or predefined punctuality requirement may be dependent on a characteristic of the color change detection reaction performed by the optical test strip, i.e. by the chemical in the reagent test region of the optical test strip.
  • the predefined time range may be between 5 seconds and 300 seconds.
  • the predefined time range may be between 5 seconds and 180 seconds. More specifically, the predefined time range may be between 5 seconds and 120 seconds. More specifically, the predefined time range may be between 10 seconds and 60 seconds. More specifically, the predefined time range may be between 13 seconds and 45 seconds.
  • Other predefined time ranges for defining capture time values to be in-time capture time values may be possible.
  • delayed capture time value is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term specifically may refer, without limitation, to a capture time value comprising a predefined time lag, e.g. a predefined delay.
  • the delayed capture time value may refer to a capture time value that is delayed with regard to the predefined time range considered to be "punctual" and/or "in time”.
  • all capture time values that are greater than an upper limit of the predefined range e.g. outside of the predefined range in a direction of increasing time, may be referred to as “delayed capture time values”.
  • the delayed capture time value may refer to a numerical indication of a sum of a delay, specifically a predefined and/or known delay, and the upper limit of the predefined range and/or predefined punctuality requirement for the in-time capture time value.
  • the delayed capture time value may differ from the in-time capture time value by at least the delay.
  • the delay may be referred to as d, wherein d may be or may comprise a positive or negative value.
  • training set is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term specifically may refer, without limitation, to a plurality of elements having known and/or predetermined differences and/or similarities.
  • the training set may be used for training a trainable model, such as a model that can be further trained and/or updated based on additional information, e.g. gathered from the training set.
  • training set of optical test strips may specifically refer, without limitation, to a plurality of optical test strips as defined above.
  • the training set of optical test strips as provided in step a) comprises a plurality of optical test strips, e.g. of optical test strips identical in construction and/or design.
  • training set of samples of bodily fluids is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term specifically may refer, without limitation, to a plurality of samples having at least one known and/or predetermined analyte concentration, e.g. determined in a laboratory environment.
  • the training set of samples of bodily fluids may comprise a plurality of samples of bodily fluids as defined above, wherein for one or more of the plurality of samples the quantitative and/or qualitative analytical measurement result value, such as the concentration of at least one analyte within the sample, is known.
  • the number of samples comprised in the training set of samples may differ from the number of optical test strips in the training set of optical test strips. Alternatively, however, the number of samples in the training set of samples may equal the number of optical test strips in the training set of optical test strips.
  • mobile device as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term specifically may refer, without limitation, to a mobile electronics device, more specifically to a mobile communication device such as a cell phone or smartphone. Additionally or alternatively, the mobile device may also refer to a tablet computer or another type of portable computer having at least one camera. Further, as will be outlined below, the mobile device may optionally comprise further elements, such as for example one or more processors.
  • the term "camera” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term specifically may refer, without limitation, to a device having at least one imaging element configured for recording or capturing spatially resolved one-dimensional, two-dimensional or even three-dimensional optical data or information.
  • the camera may comprise at least one camera chip, such as at least one CCD chip and/or at least one CMOS chip configured for recording images.
  • image specifically may relate to data recorded by using a camera, such as a plurality of electronic readings from the imaging device, such as the pixels of the camera chip.
  • training set of images may specifically relate to a plurality of images, i.e. to a plurality of image data recorded by using a camera, e.g. the camera as defined above.
  • the training set of images may refer to a plurality of images, e.g. a stack of digital images, of at least one part of one or more of the reagent test regions of the training set of optical test strips.
  • the training set of images comprises a first training subset of images and a second training subset of images.
  • the training set of images may comprise images of each of the reagent test regions of the training set of optical test strips, wherein, for example, one or more of the samples of bodily fluid may have been applied to the reagent test regions, e.g. before image capturing.
  • the training set of images may be used for determining a training set of color formation values of the reagent test regions of the training set of optical test strips, such as a plurality of color formation values for the training set of optical test strips.
  • One or more of the images of the training set of images may be of more than one reagent test region.
  • the number of images of the training set of images may differ from the number of optical test strips in the training set of optical test strips.
  • the training set of images may for example comprise separate images for each of the reagent test regions of the training set of optical test strips.
  • each image of the training set of images may be captured at the in-time capture time values and/or the delayed capture time values.
  • the images of the training set of images comprised by the first training subset of images are captured at the in-time capture time values, wherein the in-time capture time values may be different for one or more images within the first training subset of images.
  • the in-time capture time values for one or more images of the first training subset of images may be known or even pre-set.
  • the images of the training set of images comprised by the second training subset of images are captured at the delayed capture time values, wherein the delayed capture time values may be different for one or more images within the second training subset of images.
  • the delayed capture time values for one or more images of the second training subset of images may be known or even pre-set.
  • each image of the training set of images may be assigned and/or linked to at least one in-time capture time value or delayed capture time value.
  • the camera may comprise further elements, such as one or more optical elements, e.g. one or more lenses.
  • the camera may be a fix-focus camera, having at least one lens, which is fixedly adjusted with respect to the camera.
  • the camera may also comprise one or more variable lenses, which may be adjusted, automatically or manually.
  • the invention specifically shall be applicable to cameras as usually used in mobile applications such as notebook computers, tablets or, specifically, cell phones such as smart phones.
  • the camera may be part of a mobile device which, besides the at least one camera, comprises one or more data processing devices such as one or more data processors. Other cameras, however, are feasible.
  • the camera specifically may be a color camera.
  • color information may be provided or generated, such as color values for three colors R, G, B, for example also referred to as color channels.
  • a larger number of color values is also feasible, such as four color values for each pixel, for example R, G, G, B.
  • Color cameras are generally known to the skilled person.
  • the camera chip may consist of a plurality of three or more different color sensors each, such as color recording pixels like one pixel for red (R), one pixel for green (G) and one pixel for blue (B).
  • values may be recorded by the pixels, such as digital values in the range of 0 to 255, depending on the intensity of the respective color.
  • quadruples may be used, such as R, G, G, B.
  • the color sensitivities of the pixels may be generated by color filters or by appropriate intrinsic sensitivities of the sensor elements used in the camera pixels. These techniques are generally known to the skilled person.
  • processor as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term specifically may refer, without limitation, to an arbitrary logic circuitry configured for performing basic operations of a computer or system, and/or, generally, to a device which is configured for performing calculations or logic operations.
  • the processor may be configured for processing basic instructions that drive the computer or system.
  • the processor may comprise at least one arithmetic logic unit (ALU), at least one floating-point unit (FPU), such as a math coprocessor or a numeric coprocessor, a plurality of registers, specifically registers configured for supplying operands to the ALU and storing results of operations, and a memory, such as an L1 and L2 cache memory.
  • the processor may be a multicore processor.
  • the processor may be or may comprise a central processing unit (CPU).
  • the processor may be or may comprise a microprocessor, thus specifically the processor's elements may be contained in one single integrated circuitry (IC) chip.
  • the processor may be or may comprise one or more application-specific integrated circuits (ASICs) and/or one or more field-programmable gate arrays (FPGAs) or the like.
  • the processor may, for example, be a separate processor, such as a stand-alone processor or a processor integrated into a computer or computer network, separate from the mobile device.
  • the processor may be integrated into the mobile device used in step c) for capturing the training set of images.
  • the processor may be a processor of the mobile device.
  • Step e) of the determination method may comprise deriving at least two color expectation ranges.
  • the at least two color expectation ranges may be complementary, e.g. sharing at least one border.
  • the determination method may be configured for determining two complementary color expectation ranges.
  • the delay for a first of the complementary color expectation ranges the delay, specifically a first delay referred to as d 1 , may in particular not exceed a predefined acceptance threshold.
  • the acceptance threshold may specifically throughout the specification be referred to as d a .
  • the acceptance threshold d a may further be lower than the expiry threshold d max .
  • the delay specifically a second delay referred to as d 2
  • the delay may be equal to d a or may be between the acceptance threshold d a and the expiry threshold d max .
  • d a ⁇ d 2 ⁇ d max for a first of the complementary color expectation ranges the delay, specifically a first delay referred to as d 1 , may in particular not exceed a predefined acceptance threshold.
  • the acceptance threshold may specifically throughout the specification be referred to as d a .
  • the acceptance threshold d a may further be lower than the expiry threshold d max .
  • specifically d 1 ⁇ d a ⁇ d max for
  • step e) of the determination method may comprise deriving at least two complementary color expectation ranges, wherein the first color expectation range may be or may comprise colors, specifically color formation values, to be expected for an assumed reaction time value range comprising assumed reaction time values differing from the actual and/or real reaction time values by less than the acceptance threshold d a , specifically by less than an acceptable delay.
  • the first color expectation range may be or may comprise colors, specifically color formation values, derived and/or determined from images captured at in-time capture time values and delayed capture time values, wherein the delay of the delayed capture time values is smaller than the acceptable delay.
  • the second color expectation range e.g.
  • the second color expectation range may be or may comprise colors, specifically color formation values, derived and/or determined from images captured at delayed capture time values, wherein the delay of the delayed capture time values is greater or equal to the acceptable delay and below or equal to the expiry delay.
  • the first color expectation range may comprise color formation values to be expected for assumed reaction times differing from the actual and/or real reaction times by less than an acceptable delay
  • the second color expectation range may comprise color formation values to be expected for assumed reaction times differing from the actual and/or real reaction times by at least the acceptable delay but by no more than the expiry delay
  • Step d) may further comprise labelling the color formation values of the training set of color formation values with information on the capture time values, i.e. with the in-time capture time values or the delayed capture time values.
  • the labelling may be taken into consideration in step e).
  • the information on the capture time values may comprise information on whether the image was taken at the in-time capture time value or the delayed capture time value, wherein for the delayed capture time value further information, specifically whether the delay is below or above the at least one predefined expiry threshold and optionally below or above the acceptance threshold, may be comprised.
  • the color expectation range may comprise at least 80% of the color formation values for the color formation of the reagent test region of the optical test strips of the training set of optical test strips determined from images captured at one or more of the in-time capture time values and the tolerably delayed capture time values.
  • the color expectation range may comprise at least 85% of the color formation values for the color formation of the reagent test region of the optical test strips of the training set of optical test strips determined from images captured at one or more of the in-time capture time values and the tolerably delayed capture time values.
  • the color expectation range may comprise at least 90%, of the color formation values for the color formation of the reagent test region of the optical test strips of the training set of optical test strips determined from images captured at one or more of the in-time capture time values and the tolerably delayed capture time values. More specifically, in step e) the color expectation range may comprise at least 95%, of the color formation values for the color formation of the reagent test region of the optical test strips of the training set of optical test strips determined from images captured at one or more of the in-time capture time values and the tolerably delayed capture time values.
  • the color expectation range may comprise at least 97%, of the color formation values for the color formation of the reagent test region of the optical test strips of the training set of optical test strips determined from images captured at one or more of the in-time capture time values and the tolerably delayed capture time values. More specifically, in step e) the color expectation range may comprise at least 99%, of the color formation values for the color formation of the reagent test region of the optical test strips of the training set of optical test strips determined from images captured at one or more of the in-time capture time values and the tolerably delayed capture time values.
  • the color expectation range may be or may comprise at least one polygon.
  • the color expectation range may be or may comprise a two-dimensional polygon, the edges of which may correspond to the color formation values in a two-dimensional color space, such as in a color plane of at least two colors.
  • the color expectation range may be or may comprise a three-dimensional polyhedron, the edges of which may correspond to the color formation values in a three-dimensional color space.
  • the edges may be spaced apart from the color formation values, such that at least 80%, specifically at least 85%, more specifically at least 90%, more specifically at least 95%, more specifically at least 97%, more specifically at least 99%, of the color formation values for the color formation of the reagent test region of the optical test strips of the training set of optical test strips determined from images captured at one or more of the in-time capture time values and the tolerably delayed capture time values may be enclosed by the polygon and/or polyhedron.
  • the deriving in step e) may comprise determining an envelope comprising at least 80%, specifically at least 85%, more specifically at least 90%, more specifically at least 95%, more specifically at least 97%, more specifically at least 99%, of the color formation values for the color formation of the reagent test region of the optical test strips of the training set of optical test strips determined from images captured at one or more of the in-time capture time values and the tolerably delayed capture time values and further expanding the envelope by a predetermined safety factor.
  • envelope as used herein is a broad term and is to be given its ordinary and customary meaning to a person or ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term specifically may refer, without limitation, to an element and/or entity enclosing and/or covering at least one set of data.
  • the envelope may enclose, i.e.
  • the envelope may be mathematically and/or graphically determined.
  • step e) may comprise, specifically in a subsequent step, expanding the envelope by a predetermined safety factor.
  • the safety factor may specifically be predetermined and/or pre-set, such as a safety factor taking into consideration the size and/or volume of the envelope.
  • the safety factor may be or may comprise a function dependent on the envelope, i.e. on the size and/or volume of the envelope.
  • the envelope may be expanded such that a size and/or volume of the expanded envelope may exceed the size and/or volume of the envelope by at least a factor of 1.1, specifically by at least 1.2, more specifically by at least 1.5.
  • the envelope may be expanded such that 99% or even 100% of the color formation values determined from images captured at one or more of the in-time capture time values and the tolerably delayed capture time values are enclosed.
  • the safety factor may take into consideration a deviation of the distribution of the color formation values, such as the standard deviation ⁇ of the color formation values for the color formation of the reagent test region determined from images captured at one or more of the in-time capture time values and the tolerably delayed capture time values.
  • the envelope may be expanded by a factor to cover a range of at least 4 ⁇ , preferably of at least 5 ⁇ , more preferably of at least 6 ⁇ .
  • the expansion may specifically be an equally distributed expansion, such as an even and/or uniform expansion of the envelope.
  • a uniform expansion of the envelope may be performed in case the color formation values are equally distributed within the envelope.
  • An unevenly distributed expansion is also possible.
  • the envelope may be non-uniformly and/or unevenly expanded, i.e. based and/or depending on a weighted distribution of the color formation values within the envelope.
  • Step e) may specifically comprise using at least one machine-learning algorithm, specifically by training a trainable model by using the training set of color formation values.
  • machine-learning algorithm as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term specifically may refer, without limitation, to a mathematical model being trainable by using records of training data, such as comprising training input data and corresponding training output data.
  • the training output data of the record of training data may be the result that is expected to be produced by the machine-learning algorithm when being given the training input data of the same record of training data as input.
  • the deviation between this expected result and the actual result produced by the algorithm may be observed and rated by means of a "loss function".
  • This loss function may be used as a feedback for adjusting the parameters of the internal processing chain of the machine-learning algorithm.
  • the machine-learning algorithm may comprise decision trees, naive bayes classifications, nearest neighbors, neural networks, convolutional neural networks, generative adversarial net-works, support vector machines, linear regression, logistic regression, random forest and/or gradient boosting algorithms.
  • the machine-learning algorithm may be trained by using the training set of color formation values as input data and the corresponding information on the in-time capture time value and/or delayed capture time value as output data.
  • the output data may be or may comprise information on whether the respective color formation value for the color formation of the reagent test region of the optical test strips of the training set of optical test strips was determined from images captured at the in-time capture time values and the tolerably delayed capture time values or at an expired capture time, i.e. later than tolerable for safely determining an analyte concentration.
  • the machine-learning algorithm may be or may comprise a trainable color expectation range model, i.e.
  • the feedback for adjusting the parameters of the internal processing chain of the model may specifically be based on a quantitative or qualitative determination whether the color formation values corresponding to the in-time capture time values and/or tolerably delayed capture time values, i.e. the color formation values for acceptable capture time values, are within the color expectation range.
  • Other forms of feedback may be possible.
  • the color formation values may specifically be determined for at least two color channels, such as for at least two color channels selected from the group consisting of: a green color channel (G), a blue color channel (B) and a red color channel (R).
  • the color expectation range may be derived for the at least two color channels for which the color formation values are determined in step d).
  • the method may comprise step f) of attaching at least one optical test strip of the training set of optical test strips to a color reference card comprising a plurality of color reference fields having known reference color values.
  • step f) may be performed before step c).
  • at least one image of the set of images captured in step c) may further show at least part of the color reference card, specifically one or more of the color reference fields.
  • color reference card as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term specifically may refer, without limitation, to an arbitrary item having, disposed therein or disposed thereon, such as on at least one surface, the plurality of color reference fields having known color properties or optical properties, such as having a plurality of colored fields having known reference color values.
  • the color reference card may comprise a plurality of gray reference fields having known gray levels.
  • the color reference card may be a flat card comprising at least one substrate having, on at least one surface and/or disposed therein, the plurality of color reference fields having known color values and the plurality of gray reference fields having known gray levels.
  • the substrate specifically, may have a flat surface with the color reference fields and the gray reference fields disposed thereon.
  • the substrate may be or may comprise one or more of a paper substrate, a cardboard substrate, a plastic substrate, a ceramic substrate or a metal substrate. Laminate substrates are also possible.
  • the substrate as an example, may be sheet-like or flexible. It shall be noted, however, that the substrate may also be implemented into an article of use, such as into a wall of a box, a vial, a container, a medical consumable, such as a test strip, or the like.
  • the color reference card may also fully or partially be integrated into the optical test strip.
  • the at least one image of at least the part of the reagent test region of the optical test strip may fully or partially comprise an image of at least one part of the color reference card.
  • a measurement method of performing an analytical measurement based on a color formation reaction by using a mobile device having a camera and a processor comprises the following steps that, as an example, may be performed in the given order. It shall be noted, however, that a different order may generally also be possible. Further, it may also be possible to perform one or more of the method steps once or repeatedly. Further, it may also be possible to perform two or more of the method steps simultaneously or in a timely overlapping fashion. The measurement method may comprise further method steps that are not listed.
  • the measurement method comprises:
  • the same types of optical test strips may be used as in the determination method outlined above.
  • the optical test strip provided in step i) of the measurement method may be of the same or at least similar type as the plurality of optical test strips of the training set of optical test strips provided in step a) of the determination method as described above or as will be described in more detail below.
  • the sample of bodily fluid may be a sample of bodily fluid from a user, the analyte concentration of which is to be determined and thus, may previously be unknown.
  • the assumed reaction time value may differ from an actual capture time value by more than an acceptable difference. Consequently, in step viii) the assumed reaction time value may differ from the actual capture time value by no more than an acceptable difference.
  • Step vi) may comprise comparing the color formation value to at least one first color expectation range and to at least one second color expectation range determined by performing the determination method as described herein. Specifically, in step vii) if the color formation value is outside of both the first color expectation range and the second color expectation range, the assumed capture time may be considered to be not plausible and the measurement method may be aborted. Further, in step viii) different algorithms may be used for determining the concentration of the analyte from the color formation value for color formation values in the at least one first color expectation range and in the at least one second color expectation range.
  • the measurement method may in step viii) comprise:
  • the measurement method may further comprise an intensity check, such as a step of checking whether an intensity of the color formation value is above or below at least one intensity threshold.
  • an intensity check such as a step of checking whether an intensity of the color formation value is above or below at least one intensity threshold.
  • the measurement method may be aborted.
  • the measurement method may further comprise step ix) of capturing, by using the camera, at least one image of at least a part of the regent test region without having the bodily fluid applied thereto.
  • step ix) may be performed before step ii).
  • the measurement method may comprise the capturing of at least one second image, specifically a blank image of the reagent test region without having the sample of bodily fluid applied thereto.
  • the measurement method may comprise step x) of attaching the optical test strip to a color reference card comprising a plurality of color reference fields having known reference color values.
  • the color reference card may specifically be of the same type as the color reference card optionally used in the determination method as described above.
  • step x) may be performed before step iii), and, optionally, before step ii) of the measurement method, wherein specifically, the image captured in step iii) may further show at least part of the color reference card, specifically one or more of the color reference fields.
  • the applying in step ii) may further comprise confirming, specifically by a user, that the sample of bodily fluid is or has been applied to the regent test region of the optical test strip.
  • the application of step ii) may be or may comprise a confirmation of the user that the sample of bodily fluid has been applied, i.e. by pushing a button and/or other form of confirmation, e.g. by interacting with the mobile device.
  • step ii) of the measurement method may comprise prompting a user to perform one or more of applying the sample of bodily fluid to the reagent test region of the optical test strip and confirming application of the sample of bodily fluid to the reagent test regions of the optical test strip.
  • the user may be prompted to apply the sample of bodily fluid and/or the user may be prompted to confirm sample application, e.g. by providing corresponding instructions on a display of the mobile device and/or as audio instructions.
  • a determination system for determining at least one color expectation range for assessing the plausibility of an assumed reaction time value used in an analytical measurement based on a color formation reaction comprising:
  • the delay d may be smaller or equal to the expiry threshold d max .
  • d ⁇ d max the delay d may be smaller to the expiry threshold d max .
  • d ⁇ d max the delay d may be smaller to the expiry threshold d max .
  • the processor of the determination system may, for example, be a separate processor, such as a stand-alone processor or a processor integrated into a computer or computer network, separate from the at least one mobile device. Alternatively, however, the processor may be integrated into the mobile device.
  • the determination system may further comprise: E) at least one color reference card configured for having the optical test strip releasably attached thereto, the color reference card comprising a plurality of color reference fields having known reference color values, wherein the images of the training set of images further show at least part of the color reference card, specifically one or more of the color reference fields.
  • the determination system may be configured for performing the determination method as described herein.
  • the determination system may be configured for performing at least steps d) and e) of the determination method as described herein.
  • the computer program may comprise computer-executable instructions for performing the determination method according to the present invention in one or more of the embodiments enclosed herein when the instructions are executed on a determination system, i.e. on the at least one processor of the determination system, for example integrated into a computer or computer network.
  • the computer program may be stored on a computer-readable data carrier and/or on a computer-readable storage medium.
  • a computer-readable storage medium comprising instructions which, when executed by a determination system, specifically by the determination system as described herein, cause the determination system to carry out at least steps d) and e) of the determination method as also described herein.
  • computer-readable data carrier and “computer-readable storage medium” specifically may refer to non-transitory data storage means, such as a hardware storage medium having stored thereon computer-executable instructions.
  • the computer-readable data carrier or storage medium specifically may be or may comprise a storage medium such as a random-access memory (RAM) and/or a read-only memory (ROM).
  • RAM random-access memory
  • ROM read-only memory
  • a computer program product having program code means, in order to perform the determination method according to the present invention in one or more of the embodiments enclosed herein when the program is executed on a determination system, i.e. on the at least one processor of the determination system, for example integrated into a computer or computer network.
  • the program code means may be stored on a computer-readable data carrier and/or on a computer-readable storage medium.
  • a data carrier having a data structure stored thereon, which, after loading into a computer or computer network, such as into a working memory or main memory of the computer or computer network, may execute the determination method according to one or more of the embodiments disclosed herein.
  • a computer program product with program code means stored on a machine-readable carrier, in order to perform the determination method according to one or more of the embodiments disclosed herein, when the program is executed on a computer or computer network.
  • a computer program product refers to the program as a tradable product.
  • the product may generally exist in an arbitrary format, such as in a paper format, or on a computer-readable data carrier and/or on a computer-readable storage medium.
  • the computer program product may be distributed over a data network.
  • a modulated data signal which contains instructions readable by a computer system or computer network, for performing the determination method according to one or more of the embodiments disclosed herein.
  • a mobile device having at least one camera and at least one processor is disclosed.
  • the mobile device is configured for performing at least steps iv) to viii) of the measurement method as described herein.
  • the computer program may comprise computer-executable instructions for performing the measurement method according to the present invention in one or more of the embodiments enclosed herein when the instructions are executed on the processor of the mobile device.
  • the computer program may be stored on a computer-readable data carrier and/or on a computer-readable storage medium.
  • a computer-readable storage medium comprising instructions which, when executed by a mobile device having a camera and a processor, specifically by the mobile device as described herein, cause the mobile device to carry out at least steps iv) to viii) of the measurement method as also described herein.
  • a computer program product having program code means, in order to perform the measurement method according to the present invention in one or more of the embodiments enclosed herein when the program is executed on a mobile device, i.e. on the at least one processor of the mobile device, for example integrated into a computer or computer network.
  • the program code means may be stored on a computer-readable data carrier and/or on a computer-readable storage medium.
  • a data carrier having a data structure stored thereon, which, after loading into a computer or computer network, such as into a working memory or main memory of the computer or computer network, may execute the measurement method according to one or more of the embodiments disclosed herein.
  • a computer program product with program code means stored on a machine-readable carrier, in order to perform the measurement method according to one or more of the embodiments disclosed herein, when the program is executed on a computer or computer network.
  • a computer program product refers to the program as a tradable product.
  • the product may generally exist in an arbitrary format, such as in a paper format, or on a computer-readable data carrier and/or on a computer-readable storage medium.
  • the computer program product may be distributed over a data network.
  • a modulated data signal which contains instructions readable by a computer system or computer network, for performing the measurement method according to one or more of the embodiments disclosed herein.
  • kits for determining the concentration of at least one analyte in a sample of a bodily fluid, specifically a sample of bodily fluid of a user comprises the mobile device as described above, specifically the mobile device being configured for performing at least steps iv) to viii) of the measurement method as described herein.
  • the kit further comprises at least one optical test strip having at least one reagent test region.
  • the methods and devices according to the present invention provide a large number of advantages over similar methods and devices known in the art.
  • the methods and devices as described herein may increase measurement safety.
  • measurement safety may be increased by providing an effective fail safe mechanism, for example, due to the color formation value having to be within the color expectation range, in particular when performing the measurement method, in order for the concentration of the analyte to be determined.
  • the provided methods and devices may increase measurement safety, since not all and any measured color value is converted into an analyte concentration, e.g. into a blood glucose value.
  • the present methods and devices may allow for a detection of incorrect user information on a time of application of the sample.
  • the methods may specifically comprise preventing the determining of the concentration of the analyte in the bodily fluid if the plausibility assessment may not be fulfilled. Therefore, false and/or biased results of the analytical measurement may become more unlikely.
  • the proposed methods and devices may allow for an increased user handling and/or improved user friendliness of analytical measurement, i.e. by allowing a safe analytical measurement to be performed by only capturing one image, instead of capturing at least two images.
  • the overall time necessary for performing the analytical measurement may be decreased compared to known methods and devices.
  • the determination system 110 comprises at least one mobile device 112 having at least one camera 114. Further, the determination system 110 comprises a training set of optical test strips 116. The training set of optical test strips 116 comprises a plurality of optical test trips 118, each optical test strip 118 having a reagent test region 120. Further, the determination system 110 comprises a training set of samples of body fluids 122 comprising a plurality of samples of bodily fluids 124. In particular, for each of the samples of bodily fluids 124 and the training set of samples of body fluid 122 and analyte concentration, e.g. a glucose concentration, may be known. Furthermore, the determination system 110 comprises at least one processor 126.
  • the processor 126 of the determination system 110 may, for example, be a separate processor 126. Alternatively however, and as illustrated in Figure 1 , the processor 126 may be integrated into the mobile device 112, such that the processor 126 may be a processor 126 of the mobile device 112.
  • the processor 126 is configured for retrieving a training set of images comprising images captured with the camera 114 of the mobile device 112.
  • the training set of images comprises a first training subset of images and a second training subset of images, wherein the images of the first training subset of images are captured at an in-time capture time value and wherein the images of the second training subset of images are captured at a delayed capture time value.
  • the processor 126 is configured for retrieving both the first training subset of images and the second training subset of images, specifically from the camera 114.
  • the processor 126 is configured for determining a training set of color formation values from the images of the training set of images.
  • the training set of color formation values comprises color formation values of at least one color channel for the color formation of the reagent test region 120 each of the optical test strips 118 of the training set of optical test strips 116 for in-time capture time values and for delayed capture time values.
  • the processor 126 is configured for deriving at least one color expectation range 128 for the at least one color channel from the training set of color formation values, wherein the color expectation range 128 defines an expected range of color formation values for in-time capture time values and tolerably delayed capture time values, wherein for the tolerably delayed capture time values the delay d does not exceed at least one predefined expiry threshold d max .
  • Figure 1 also illustrates an embodiment of a kit 130 configured for determining the concentration of at least one analyte in a sample of bodily fluid 124.
  • the sample of bodily fluid 124 may specifically comprise a bodily fluid of a user, such as a sample having an unknown analyte concentration.
  • a sample is exemplary illustrated on the far right of the figure.
  • the kit 130 comprises at least one optical test strip 118 having at least one reagent test region 120.
  • such an optical test strip 118 i.e. a singular optical test strip 118, is exemplary illustrated on the far right of the figure.
  • the kit 130 comprises a mobile device 112 having at least one camera 114 and at least one processor 126.
  • the mobile device 112 of the kit 130 may be the same mobile device 112 of the determination system 110.
  • the kit 130 and the determination system 110 each comprise their own mobile device 114, i.e. distinct and separate mobile devices 112.
  • the determination system 110 may specifically be configured for at least partially performing a determination method 132.
  • An exemplary embodiment of the determination method 132 is shown in Figure 2 .
  • the determination method 132 is configured for determining at least one color expectation range 128 for assessing the plausibility of an assumed reaction time value used in an analytical measurement based on a color formation reaction.
  • the determination method 132 comprises the following steps:
  • the color expectation range 128 may, for example, be or may comprise a polygon, such as a two-dimensional polygon in a color plane.
  • the color plane may show color values in a red color channel 144, wherein on a vertical axis the color plane may show color values in a green color channel 146.
  • color formation values of an exemplary training set of color formation values are illustrated.
  • the color expectation range 128 may comprise at least 80% of the color formation values for the color formation of the reagent test region of the optical test strips of the training set of optical test strips determined from images captured at one or more of the in-time capture time values and the tolerably delayed capture time values, i.e. at least 80% of these color formation values may be enclosed by the polygon shape of the color expectation range 128.
  • At least two complementary color expectation ranges 128, i.e. a first color expectation range 148 and a second color expectation range 150, may be determined.
  • the first color expectation range 148 may be or may comprise colors, specifically color formation values, to be expected for an assumed reaction time value differing from the actual and/or real reaction time value by no more than an acceptable delay, wherein the acceptable delay may correspond to a predefined and/or predetermined acceptance threshold d a .
  • the second color expectation range 150 may be or may comprise colors, specifically color formation values, to be expected for an assumed reaction time value differing from the actual and/or real reaction time value by more than the acceptable delay but by no more than an expiry delay, wherein the expiry delay may correspond to the predefined and/or predetermined expiry threshold d max .
  • the first color expectation range 148 may also be denoted by "I”
  • the second color expectation range 150 may also be denoted by "II"
  • an area outside of both the first color expectation range 148 and the second color expectation range 150 may be denoted by "III".
  • color formation values are illustrated for the in-time capture time values and the delayed capture time values.
  • Other selections of acceptable delays and/or expiry delays may be possible.
  • the color expectation range 128 may be or may comprise a three-dimensional form, such as a polyhedron.
  • the color expectation range 128 may be formed by a polygon in a two-dimensional color space, such as a polygon in the color plane of the red color channel 144 and the green color channel 146, that has been expanded into a third dimension, for example referring to a blue color channel 170 or, alternatively, to an intensity value, i.e. a value in an intensity dimension, for example an absolute intensity value of the values of the green color channel 146.
  • the color expectation range 128 may be limited in the direction of the blue color channel 170 by an upper plane 172 as well as by a lower plane 174. Other forms and/or geometries of the color expectation range 128 may be possible.
  • the at least one color expectation range 128 may be used for assessing the plausibility of an assumed reaction time value used in an analytical measurement based on a color formation reaction.
  • Such an analytical measurement may be performed by a measurement method 176. Exemplary embodiments of the measurement method 176 are illustrated in Figures 5 and 6 .
  • the measurement method 176 comprises the following steps:
  • the measurement method 176 may further comprise an intensity check 196, such as a step of checking whether an intensity of the color formation value is above or below at least one intensity threshold.
  • an intensity check 196 such as a step of checking whether an intensity of the color formation value is above or below at least one intensity threshold.
  • the measurement method may be aborted.
  • the color formation value fails the intensity check, the color formation value may be considered not plausible and thus, the measurement method 176 may be aborted.
  • the color expectation range 128 may be a variable color expectation range, such as the basic points of the polygon shape and/or the parameters of the defining planes.
  • these basic points and/or parameters may be provided by means of metadata, which metadata are associated with a color card, to an application (on a user's mobile device) which allows to vary the basic points and/or parameters at a later point in time when needed.
  • the variation of the color expectation range may be carried out in an optional method step before starting to carry out the measurement method 176.
  • step vi) 188 of the measurement method 176 may specifically comprise separate steps for comparing the color formation value to the first color expectation range 148.
  • it may be checked whether the color formation value is above the lower plane 174.
  • it may be checked whether the color formation value is below the upper plane 172.
  • it may be checked whether the color formation value is within the first polygon shape "I" in the color plane defined by the red color channel 144 and the green color channel 146.
  • the color formation value fails any of checks 198 to 202, the color formation value may be considered not plausible and the method may be aborted, according to step vii) 190. Further optionally, after aborting the method, the measurement method 176 may comprise showing an error message 204. The same checks may be performed for the second color expectation range 150. This step is illustrated in Figure 6 by reference number 206. For each of the first and the second color expectation ranges 148 and 150 different post processing code functions may be used for determining the concentration of the analyte.
  • a flag is set whether the color formation value is comprised in the first color expectation range 148, then the flag is set to "I” 208, or comprised in the second color expectation range 150, then the flag is set to "II” 210.
  • a first mathematical correlation function such as a mathematical function " f "
  • a mathematical function "g” may be used for determining the analyte concentration from the color formation value
  • a mathematical function "g” may be used for the second color expectation range 150.
  • Figure 7 shows a graphical illustration of a diagram indicating a relationship between actual blood glucose values and determined blood glucose values by using both common methods and systems and using present methods and systems for the determination of blood glucose concentrations.
  • the diagram illustrated in Figure 7 indicates the relationship between the actual blood glucose value in mg/dl 212 and the measured blood glucose value in mg/dl 214.
  • values indicated by a cross show the relationship for normal measurements, i.e. measurements performed without provocation, specifically without wrongful and/or inappropriate handling procedures, wherein values indicated with circles show the relationship for provocational measurements, i.e. for measurements with wrongful and/or inappropriate user handling procedures, performed by using the present methods and devices.
  • provocational measurements i.e. for measurements with wrongful and/or inappropriate user handling procedures
  • Figure 7 show regions A to E of an Error-Grid-Analysis, specifically regions A to E of the Parkes Error Grid, quantifying clinical accuracy of a determined blood glucose concentration compared to an actual blood glucose concentration.
  • the measurements illustrated in Figure 7 are based on the same samples and assumed reaction times. In particular, the same samples and assumed reaction times have been used for determining the blood glucose values for both measurements.
  • Table 1 indicates the number of determined blood glucose values for a set of provocational measurements performed by using known methods and devices and the same measurements performed by using the present methods and devices.
  • the set of provocational measurements as a reference and/or for controlling purposes, further included a total number of 15 "normal" measurements performed without provocation, specifically without wrongful and/or inappropriate handling procedures, used as reference measurements.
  • Table 1 Number of determined blood glucose values for both using known methods and devices and using present methods and devices Legend A B C D E number of determined blood glucose values for known methods and devices 89 14 2 2 0 number of determined blood glucose values for present methods and devices 19 0 0 0 0
  • the values of measurements performed by known methods and devices provide blood glucose values for almost all measurements, wherein in measurements according to the present invention, no blood glucose values are provided for assumed time spans considered to be not plausible.
  • blood glucose values were determined for all of the 15 normal measurements used as a reference within the set of provocational measurements.

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Claims (17)

  1. Méthode de détermination permettant de déterminer au moins un intervalle d'attente de couleur (128) pour évaluer la plausibilité d'une valeur supposée de temps de réaction utilisée dans une mesure analytique basée sur une réaction de formation de couleur, la méthode comprenant :
    a) la fourniture d'un ensemble d'entraînement de bandelettes de test optiques (116), chaque bandelette de test optique (118) ayant une région de test réactive (120) ;
    b) la fourniture d'un ensemble d'entraînement d'échantillons de fluides corporels (122) et l'application d'au moins l'un des échantillons de fluide corporel (124) sur la région de test réactive de chaque bandelette de test optique (118) de l'ensemble d'entraînement de bandelettes de test optiques (116) ;
    c) la capture, par au moins un dispositif mobile (112) ayant au moins une caméra (114), d'un ensemble d'entraînement d'images comprenant
    - un premier sous-ensemble d'entraînement d'images, le premier sous-ensemble d'entraînement d'images comprenant des images d'au moins une partie d'au moins certaines des régions de test réactives (120) de l'ensemble d'entraînement de bandelettes de test optiques (116) sur lesquelles est appliqué l'échantillon de fluide corporel capturées à des valeurs de temps de capture en temps réel, la valeur de temps de capture faisant référence au temps qui s'est écoulé entre l'application de l'échantillon à l'étape b) et la capture de l'image ;
    - au moins un deuxième sous-ensemble d'entraînement d'images, l'au moins un deuxième sous-ensemble d'entraînement d'images comprenant des images d'au moins une partie d'au moins certaines des régions de test réactives (120) de l'ensemble d'entraînement de bandelettes de test optiques (116) sur lesquelles est appliqué l'échantillon de fluide corporel capturées à des valeurs de temps de capture retardées ;
    d) la détermination d'un ensemble d'entraînement de valeurs de formation de couleur à partir des images de l'ensemble d'entraînement d'images, l'ensemble d'entraînement de valeurs de formation de couleur comprenant des valeurs de formation de couleur d'au moins un canal de couleur pour la formation de couleur de la région de test réactive (120) des bandelettes de test optiques (118) de l'ensemble d'entraînement de bandelettes de test optiques (120) pour les valeurs de temps de capture en temps réel et pour les valeurs de temps de capture retardées ; et
    e) la dérivation de l'au moins un intervalle d'attente de couleur (128) pour l'au moins un canal de couleur à partir de l'ensemble d'entraînement de valeurs de formation de couleur, l'intervalle d'attente de couleur définissant un intervalle attendu de valeurs de formation de couleur pour les valeurs de temps de capture en temps réel et pour les valeurs de temps de capture retardées de manière tolérable, dans laquelle pour les valeurs de temps de capture retardées de manière tolérable le retard d ne dépasse pas au moins un seuil d'expiration prédéfini dmax.
  2. Méthode de détermination selon la revendication précédente, dans laquelle l'étape e) comprend la dérivation d'au moins deux intervalles d'attente de couleur complémentaires (148, 150).
  3. Méthode de détermination selon la revendication précédente, dans laquelle pour un premier des intervalles d'attente de couleur complémentaires (148) un retard d1 ne dépasse pas un seuil d'acceptabilité da prédéfini inférieur au seuil d'expiration dmax, spécifiquement d1 < da< dmax, et pour un deuxième des intervalles d'attente de couleur complémentaires (150) un retard d2 est égal à da ou entre le seuil d'acceptabilité da et le seuil d'expiration dmax, spécifiquement da ≤ d2 ≤ dmax.
  4. Méthode de détermination selon l'une quelconque des revendications précédentes, dans laquelle l'étape d) comprend en outre le marquage des valeurs de formation de couleur de l'ensemble d'entraînement de valeurs de formation de couleur avec les informations sur les valeurs de temps de capture.
  5. Méthode de détermination selon l'une quelconque des revendications précédentes, dans laquelle à l'étape e) l'intervalle d'attente de couleur (128) comprend au moins 80 %, spécifiquement au moins 85 %, plus spécifiquement au moins 90 %, plus spécifiquement au moins 95 %, plus spécifiquement au moins 97 %, plus spécifiquement au moins 99 %, des valeurs de formation de couleur pour la formation de couleur de la région de test réactive des bandelettes de test optiques de l'ensemble d'entraînement de bandelettes de test optiques déterminées à partir des images capturées à une ou plusieurs parmi les valeurs de temps de capture en temps réel et les valeurs de temps de capture retardées de manière tolérable.
  6. Méthode de détermination selon l'une quelconque des revendications précédentes, dans laquelle la dérivation à l'étape e) comprend la détermination d'une enveloppe comprenant au moins 80 % des valeurs de formation de couleur pour la formation de couleur de la région de test réactive (120) des bandelettes de test optiques (118) de l'ensemble d'entraînement de bandelettes de test optiques (116) déterminées à partir des images capturées à une ou plusieurs parmi les valeurs de temps de capture en temps réel et les valeurs de temps de capture retardées de manière tolérable et l'expansion supplémentaire de l'enveloppe par un facteur de sécurité prédéterminé.
  7. Méthode de détermination selon l'une quelconque des revendications précédentes, dans laquelle l'étape e) comprend l'utilisation d'au moins un algorithme d'apprentissage machine.
  8. Méthode de mesure permettant de réaliser une mesure analytique basée sur une réaction de formation de couleur en utilisant un dispositif mobile (112) ayant une caméra (114) et un processeur (126), la méthode comprenant :
    i) la fourniture d'au moins une bandelette de test optique (118) ayant au moins une région de test réactive (120) ;
    ii) l'application d'un échantillon de fluide corporel (124) sur la région de test réactive (120) de la bandelette de test optique (118) ;
    iii) la capture, en utilisant la caméra (114), d'au moins une image d'au moins une partie de la région de test réactive (120) sur laquelle est appliqué le fluide corporel ;
    iv) la détermination d'une valeur supposée de temps de réaction correspondant au temps qui s'est écoulé entre un temps supposé d'application de l'échantillon à l'étape ii) et la capture de l'image à l'étape iii) ;
    v) la détermination d'une valeur de formation de couleur d'au moins un canal de couleur pour une formation de couleur de la région de test réactive (120) en utilisant l'image ;
    vi) la comparaison, pour l'au moins un canal de couleur, de la valeur de formation de couleur avec au moins un intervalle d'attente de couleur (128) déterminé en réalisant la méthode de détermination selon l'une quelconque des revendications précédentes ;
    vii) si la valeur de formation de couleur est à l'extérieur de l'au moins un intervalle d'attente de couleur (128), la considération que la valeur supposée de temps de réaction n'est pas plausible et l'interruption de la méthode de mesure ; et
    viii) si la valeur de formation de couleur est à l'intérieur de l'intervalle d'attente de couleur (128), la considération que la valeur supposée de temps de réaction est plausible et la détermination d'une concentration de l'analyte dans l'échantillon de fluide corporel en utilisant la valeur de formation de couleur.
  9. Méthode de mesure selon la revendication précédente, dans laquelle l'étape vi) comprend la comparaison de la valeur de formation de couleur avec au moins un premier intervalle d'attente de couleur (148) et avec au moins un deuxième intervalle d'attente de couleur (150) déterminés en réalisant la méthode de détermination selon l'une quelconque des revendications 2 à 7, et dans laquelle à l'étape vii) si la valeur de formation de couleur est à l'extérieur à la fois du premier intervalle d'attente de couleur et du deuxième intervalle d'attente de couleur, le temps de capture supposé est considéré comme n'étant pas plausible et la méthode de mesure est interrompue, dans laquelle à l'étape viii) différents algorithmes sont utilisés pour déterminer la concentration de l'analyte à partir de la valeur de formation de couleur pour les valeurs de formation de couleur dans l'au moins un premier intervalle d'attente de couleur et dans l'au moins un deuxième intervalle d'attente de couleur.
  10. Méthode de mesure selon la revendication précédente, dans laquelle à l'étape viii) :
    - si la valeur de formation de couleur est à l'intérieur du premier intervalle d'attente de couleur (148), la valeur supposée de temps de réaction est considérée comme étant plausible et la concentration de l'analyte est déterminée en utilisant la valeur de formation de couleur et la valeur supposée de temps de réaction ; et
    - si la valeur de formation de couleur est à l'intérieur du deuxième intervalle d'attente de couleur (150), la valeur supposée de temps de réaction est considérée comme étant plausible et la concentration de l'analyte est déterminée en utilisant la valeur de formation de couleur et un retard prédéfini pour le deuxième intervalle d'attente de couleur ajouté à la valeur supposée de temps de réaction.
  11. Méthode de mesure selon l'une quelconque des deux revendications précédentes, dans laquelle la méthode comprend en outre l'étape ix) de capture, en utilisant la caméra (114), d'au moins une image d'au moins une partie de la région de test réactive (120) sur laquelle n'est pas appliqué le fluide corporel, dans laquelle l'étape ix) est réalisée avant l'étape ii).
  12. Méthode de mesure selon l'une quelconque des deux revendications précédentes, dans laquelle la méthode comprend en outre l'étape x) de fixation de la bandelette de test optique (118) à une carte de référence de couleur comprenant une pluralité de champs de référence de couleur ayant des valeurs de couleurs de référence connues, dans laquelle l'étape x) est réalisée avant l'étape iii, et dans laquelle l'image capturée à l'étape iii) révèle en outre au moins une partie de la carte de référence de couleur.
  13. Système de détermination (110) permettant de déterminer au moins un intervalle d'attente de couleur (128) pour évaluer la plausibilité d'une valeur supposée de temps de réaction utilisée dans une mesure analytique basée sur une réaction de formation de couleur, comprenant :
    A) au moins un dispositif mobile (112) ayant au moins une caméra (114) ;
    B) un ensemble d'entraînement de bandelettes de test optiques (116), chaque bandelette de test optique (118) ayant une région de test réactive (120) ;
    C) un ensemble d'entraînement d'échantillons de fluides corporels (126) comprenant une pluralité d'échantillons de fluides corporels (128) ; et
    D) au moins un processeur (126), le processeur (126) étant configuré pour :
    - récupérer un ensemble d'entraînement d'images, l'ensemble d'entraînement d'images comprenant des images, capturées avec la caméra (114), d'au moins une partie d'au moins certaines des régions de test réactives (120) de l'ensemble d'entraînement de bandelettes de test optiques (116) sur lesquelles est appliqué l'échantillon de fluide corporel (124) capturées à une valeur de temps de capture en temps réel, la valeur de temps de capture faisant référence au temps qui s'est écoulé entre l'application de l'échantillon et la capture de l'image, l'ensemble d'entraînement d'images comprenant en outre des images, capturées avec la caméra (114), d'au moins une partie d'au moins certaines des régions de test réactives (120) de l'ensemble d'entraînement de bandelettes de test optiques (116) sur lesquelles est appliqué l'échantillon de fluide corporel (124) capturées à des valeurs de temps de capture retardées ;
    - déterminer un ensemble d'entraînement de valeurs de formation de couleur à partir des images de l'ensemble d'entraînement d'images, comprenant des valeurs de formation de couleur d'au moins un canal de couleur pour la formation de couleur de la région de test réactive (120) des bandelettes de test optiques (118) de l'ensemble d'entraînement de bandelettes de test optiques (116) pour les valeurs de temps de capture en temps réel et pour les valeurs de temps de capture retardées ; et
    - dériver l'au moins un intervalle d'attente de couleur (128) pour l'au moins un canal de couleur à partir de l'ensemble d'entraînement de valeurs de formation de couleur, l'intervalle d'attente de couleur (128) définissant un intervalle attendu de valeurs de formation de couleur pour les valeurs de temps de capture en temps réel et les valeurs de temps de capture retardées de manière tolérable, dans lequel pour les valeurs de temps de capture retardées de manière tolérable le retard d ne dépasse pas au moins un seuil d'expiration prédéfini dmax.
  14. Système de détermination (110) selon la revendication précédente, dans lequel le système de détermination comprend en outre :
    E) au moins une carte de référence de couleur configurée pour avoir la bandelette de test optique fixée de manière amovible à celle-ci, la carte de référence de couleur comprenant une pluralité de champs de référence de couleur ayant des valeurs de couleur de référence connues, dans lequel les images de l'ensemble d'entraînement d'images révèlent en outre au moins une partie de la carte de référence de couleur, spécifiquement un ou plusieurs des champs de référence de couleur.
  15. Système de détermination (110) selon l'une quelconque des deux revendications précédentes, dans lequel le système de détermination est configuré pour réaliser au moins les étapes d) et e) de la méthode de détermination selon l'une quelconque des revendications précédentes faisant référence à une méthode de détermination.
  16. Dispositif mobile (112) ayant au moins une caméra (114) et au moins un processeur (126), le dispositif mobile (112) étant configuré pour réaliser au moins les étapes iv) à viii) de la méthode de mesure selon l'une quelconque des revendications précédentes faisant référence à une méthode de mesure.
  17. Kit (130) permettant de déterminer la concentration d'au moins un analyte dans un échantillon d'un fluide corporel (124), le kit (130) comprenant le dispositif mobile (112) selon la revendication précédente, le kit (130) comprenant en outre au moins une bandelette de test optique (118) ayant au moins une région de test réactive (120).
EP23703456.6A 2022-02-11 2023-02-09 Méthode de détermination d'un intervalle d'attente de couleur pour évaluer la plausibilité d'une valeur supposée de temps de réaction utilisée dans une mesure analytique basée sur une réaction de formation de couleur, système et dispositif mobile Active EP4476525B1 (fr)

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PCT/EP2023/053145 WO2023152200A1 (fr) 2022-02-11 2023-02-09 Procédés et dispositifs pour déterminer la concentration d'au moins un analyte dans un fluide corporel

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US20170098137A1 (en) 2012-08-08 2017-04-06 Scanadu Incorporated Method, apparatus and system for detecting and determining compromised reagent pads by quantifying color changes induced by exposure to a hostile environment
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CA2883969C (fr) 2012-09-04 2021-07-13 Edward L. Mamenta Systeme et procede pour des dosages rapides analyses de facon spatiotemporelle
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KR102016989B1 (ko) 2017-11-29 2019-09-02 한양대학교 산학협력단 타이머를 포함하는 소변 검사용 스트립, 소변 검사용 스트립 검출 및 분석 방법
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CN118679370A (zh) 2024-09-20
WO2023152200A1 (fr) 2023-08-17
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KR20240144948A (ko) 2024-10-04
US20240426808A1 (en) 2024-12-26
EP4476525A1 (fr) 2024-12-18
JP2025507364A (ja) 2025-03-18

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